First U.S. Patient Gets Stem Cell Trachea Transplant

Christopher Lyles, 30, of Abingdon, Md, exhausted the limited treatment options available in the U.S. for his tracheal cancer. But Lyles read about an experimental tracheal transplant procedure surgeons performed in Europe using adult stem cells.

"Every surgeon told me it was inoperable," said Lyles. "It was hard to hear that."

Lyles reached out to Dr. Paolo Macchiarini, director of the Advanced Center for Translational Regenerative Medicine at the Karolinska Institute in Stockholm, who was the head surgeon in previous transplant cases.

After a 12 hour procedure in Sweden, Lyles was breathing through a lab grown windpipe that doctors fashioned from his own stem cells.

Doctors regenerated tissue from Lyles' bone marrow stem cells to create a trachea biologically identical to Lyles' original organ. Lyle underwent the transplant in November and arrived back home Wednesday.

Within three months, Lyles was able to eat and speak on his own, he said.

"I'm going one step further every day," said Lyle.

According to Dr. Mark Iannettoni, head of the department of cardiothoracic surgery at University of Iowa, a trachea is a fragile organ because it is mostly cartilage, which has a poor blood supply.

"Once damaged, it is difficult to get it to heal correctly," said Iannettoni.

In June 2011, Lyles was diagnosed with a rare form of trachea cancer. Unlike some patients with the same condition, Lyle tumor extended below his thyroid gland and did not affect his voice box.

Trachea cancer is resistant to chemotherapy and radiation and attempts to replace the trachea with mechanical devices have not been effective.

Lyles first underwent seven rounds of chemotherapy and 33 rounds of radiation treatment between July and September.

Using a patient's own stem cells not only could help to rebuild the fragile tissue, but also potentially could bypass the risk of having the organ rejected, according to Dr. Eric Lambright, surgical director of lung transplant at Vanderbilt University Medical Center, who was not involved with the procedure.

"These patients [are] otherwise sentenced to rather significant horrible quality of life related to their tumors and heroic measures may indeed be very appropriate," said Lambright.

After surgery, Lyles contracted pneumonia in both lungs, which slowed his recovery.

he experimental procedure, not covered by medical insurance, cost between $300,000 to $600,000, Lyles said. The family asked for at least $300,000 donation through the non-profit organization Help Hope Live, which works to fund uninsured transplant-related expenses.

"I hope my situation can help other people and we can lobby for those that don't have a voice," Lyles said.

Macchiarini and his surgical team have been performing the transplants since 2008, when they transplanted a trachea using adult stem cells on a woman who suffered from tuberculosis. The procedure was first implemented on patients with tracheal cancer in August 2010.

According to Macchiarini, the team collected stem cells from the two patients' nose and bone marrow, and grew two different types of tissues from the cells that resembled the different surfaces of the trachea. The tissues covered the outer and inner linings of the donor trachea.

Trachea Transplant for Cancer Patients

The team transplanted a new windpipe with tissue grown from her own stem cells and did not need to administer anti-rejection drugs, according to the case report, published in the December 2008 Lancet.

While the procedure seemed to have worked in a few patients, many experts said the method is still in the earliest stages of development.

"This is a research project and not a proven therapy," said Dr. Larry Goldstein, director of the stem cell program at University of California San Diego. "There's an important step from innovative therapy to the research needed to bring the innovative therapy to a large number of people."

In fact, Goldstein said there's a lot more information needed to know exactly how the procedure worked.

Lambright said it is still early to tell if the procedure works for a larger number of patients.

"We are a long ways away from knowing whether or not any of this has real durable application," said Lambright.

But Lyles said that without the procedure his doctors told him he may not have been alive today.

"I think this is a viable solution to this type of cancer," said Lyles. "I'm happy to have been a part of it."

Macchiarini said this procedure could pave the way for other challenging transplants including the heart valve, chest wall, lungs and the esophagus.

"We need to be very cautious and don't make hope for patients with cancer, because this is experimental," said Macchiarini. "But so far the patients have had incredible results for an untreatable cancer."